NCT06081621 is a Phase 2 clinical trial of REGEND001 in Idiopathic Pulmonary Fibrosis, sponsored by Regend Therapeutics.

Who is sponsoring NCT06081621?

NCT06081621 is sponsored by Regend Therapeutics.

What drugs are being tested in NCT06081621?

Interventions in NCT06081621: REGEND001, Placebo.

What condition does NCT06081621 study?

NCT06081621 studies Idiopathic Pulmonary Fibrosis.

Is NCT06081621 still recruiting?

NCT06081621 is currently completed. Last updated 18 March 2026.

Last reviewed 2026-03-18 · How we verify

NCT06081621

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Clinical Study to Evaluate the Efficacy and Safety of REGEND001 Cell Therapy on Idiopathic Pulmonary Fibrosis (IPF)

Completed Phase 2 Last updated 18 March 2026

What this trial tests

Phase 2 trial testing REGEND001 in Idiopathic Pulmonary Fibrosis in 23 participants. Completed in 14 March 2025.

Timeline

11 December 2023

Primary endpoint
14 March 2025

14 March 2025

Quick facts

Lead sponsor	Regend Therapeutics
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	23
Start date	11 December 2023
Primary completion	14 March 2025
Estimated completion	14 March 2025
Sites	4 locations across China

Drugs / interventions tested

REGEND001 — full drug profile →
Placebo

Conditions studied

Idiopathic Pulmonary Fibrosis — all drugs for Idiopathic Pulmonary Fibrosis →

Sponsor

Regend Therapeutics — full company profile →

Who can join

Adults 40 to 75, any sex, with Idiopathic Pulmonary Fibrosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Idiopathic pulmonary fibrosis (IPF) is a serious chronic (long term) disease with injury of lung tissues. REGEND001 is a cell therapy product, made from bronchial basal cells with ability to regenerate lung tissue, is promising to IPF treatment. This is a multi-center, randomized, double-blinded, parallel and placebo-controlled phase II clinical study to evaluate the efficacy and safety of REGEND001 in IPF patients.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

Lung regeneration: diverse cell types and the therapeutic potential.
Chen Y, Li Z, Ji G, Wang S, et al · · 2024 · cited 24× · PMID 38405059 · DOI 10.1002/mco2.494
Autologous P63+ lung progenitor cell transplantation in idiopathic pulmonary fibrosis: a phase 1 clinical trial.
Zhang S, Zhou M, Shao C, Zhao Y, et al · · 2025 · cited 4× · PMID 40036154 · DOI 10.7554/elife.102451
Emerging pharmacological options in the treatment of idiopathic pulmonary fibrosis (IPF).
Aribindi K, Liu GY, Albertson TE. · · 2024 · cited 4× · PMID 39192604 · DOI 10.1080/17512433.2024.2396121
Idiopathic Pulmonary Fibrosis, Today and Tomorrow: Certainties and New Therapeutic Horizons.
Giulianelli G, Cocconcelli E, Fiorentù G, Bernardinello N, et al · · 2025 · cited 3× · PMID 40323570 · DOI 10.1007/s41030-025-00296-0
Most Promising Emerging Therapies for Pulmonary Fibrosis: Targeting Novel Pathways.
Carriera L, Lipsi R, Dodaj M, Inchingolo R, et al · · 2026 · cited 2× · PMID 41595688 · DOI 10.3390/biomedicines14010154

Verify or expand the search:

Other trials of REGEND001

Trials testing the same drug.

NCT05657184 — Treatment of Idiopathic Pulmonary Fibrosis (IPF) by REGEND001 · Phase 1 · completed

Other recruiting trials for Idiopathic Pulmonary Fibrosis

Currently open trials in the same condition.

NCT05988463 — Dose-Escalation Study of Artesunate Patients With IPF · Phase 1 · recruiting
NCT06241560 — A Study in People With Idiopathic Pulmonary Fibrosis to Test Whether Pirfenidone Influences the Amount of BI 1015550 in · Phase 2 · recruiting
NCT07407543 — A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SRN001 in Healthy Korean and Cauc · Phase 1 · recruiting
NCT07036523 — A Study to Find Out Whether BI 765423 Has an Effect on Lung Function in People With Idiopathic Pulmonary Fibrosis (IPF) · Phase 2 · recruiting
NCT07225296 — A Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics o · Phase 1 · recruiting

Other Regend Therapeutics trials

Trials by the same sponsor.

NCT07355868 — Treatment of Chronic Obstructive Pulmonary Disease (COPD) by REGEND007 Cell Therapy · EARLY_PHASE1 · recruiting
NCT07359963 — Treatment of Idiopathic Pulmonary Fibrosis (IPF) by REGEND007 Cell Therapy · EARLY_PHASE1 · not yet recruiting
NCT05638776 — Treatment of Chronic Obstructive Pulmonary Disease (COPD) With Diffusion Capacity Defect by REGEND001 Cell Therapy · Phase 2 · completed
NCT05657184 — Treatment of Idiopathic Pulmonary Fibrosis (IPF) by REGEND001 · Phase 1 · completed
NCT03188627 — Autologous Bronchial Basal Cell Transplantation for Treatment of COPD · Phase 1, PHASE2 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT06081621 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Regend Therapeutics
Last refreshed: 18 March 2026

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06081621.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing